Scientists check how donor skin graft heals in breast reconstruction
NCT ID NCT05744414
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study examines how AlloMend®, a graft made from donated human skin, integrates with a patient's own tissue during breast reconstruction. Researchers will analyze tissue samples from 30 women who had the graft placed with a tissue expander, looking for signs of cell growth, blood vessel formation, and healing. The goal is to better understand how the body accepts the graft, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AlloMend® acellular dermal matrix (a graft material made from donated human skin, processed to support tissue regeneration)
- What this could lead to
- If successful, this study could confirm that AlloMend® safely integrates with the body, supporting its use in breast reconstruction procedures.
- What could go wrong
- This is a small, early-stage study (30 participants) focused on tissue analysis, not on proving clinical benefits. Results may not apply to all patients or guarantee better outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults 18 years of age or greater who have undergone a pre-pectoral placement of tissue expanders for breast reconstruction and will have a histological evaluation of the AlloMend® Acellular Dermal Matrix and native tissue at time of permanent breast implantation
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥18 years of age; * AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction; * Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant; * Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol. Exclusion Criteria: * Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to consent to participate in the clinical study; * Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Janiga MDs Plastic Surgery and Cosmetic Center
Reno, Nevada, 89521, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.